Cleared Traditional

K962009 - UROSTYM

K962009 is an FDA 510(k) clearance for UROSTYM, manufactured by Laborie Medical Technologies, Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code KPI cleared through the Traditional 510(k) pathway after a 363-day FDA review.

K962009 · Laborie Medical Technologies, Ltd. · Gastroenterology & Urology device
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May 1997
Decision
363d
Days
Class 2
Risk

K962009 is an FDA 510(k) clearance for the UROSTYM. Classified as Stimulator, Electrical, Non-implantable, For Incontinence (product code KPI), Class II - Special Controls.

Submitted by Laborie Medical Technologies, Ltd. (South Burlington, US). The FDA issued a Cleared decision on May 20, 1997 after a review of 363 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5320 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Laborie Medical Technologies, Ltd. devices

FDA 510(k) Submission Details - K962009

510(k) Number K962009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1996
Decision Date May 20, 1997
Days to Decision 363 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
233d slower than avg
Panel avg: 130d · This submission: 363d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPI Device Classification - Class 2, Special Controls

Product Code KPI Stimulator, Electrical, Non-implantable, For Incontinence
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5320
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KPI Stimulator, Electrical, Non-implantable, For Incontinence

All 54
Devices cleared under the same product code (KPI) and FDA review panel - the closest regulatory comparables to K962009.
INNOSENSE PELVIC FLOOR STIMULATION AND ELECTROMYOGRAPHY SYSTEM
K971527 · Empi · Jun 1997
VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE - TAMPON
K971541 · Hollister, Inc. · Jun 1997
LIBERTY PLUS SYSTEM(PFS-300)/VAGINAL PROBE, LIBERTY PLUS(PFS-044)
K970077 · Utah Medical Products, Inc. · May 1997
MINNOVA PELVIC FLOOR STIMULATION SYSTEM
K970307 · Empi · Apr 1997
VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE-SMALL
K970602 · Hollister, Inc. · Apr 1997
LIBERTY RECTAL PELVIC FLOOR EXERCISER
K964526 · Utah Medical Products, Inc. · Feb 1997